FDAClass IIAugust 15, 2012

I-STAT PT/INR cartridge Abbott Point of Care Inc. recall

I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral…

Why was I-STAT PT/INR cartridge Abbott Point of Care Inc. recalled?

The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12

Product
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral…
Recalling firm
Abbott Point Of Care Inc.
Quantity
2,950,296 cartridges US; 156,408 cartridges OUS
Distribution
Worldwide Distribution -- (USA) nationwide
Recall date
August 15, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls